Corneal Graft Assemblies for Improved Surgical Operations

ABSTRACT

Assemblies for storing, handling, transporting, viewing, evaluating, and/or shipping corneal tissue are provided. The assembly includes a corneal tissue carrier within a vial, the transport vial removably coupled to a stabilization base, wherein the ease of access to the graft carrier allows administering the corneal tissue sample to a patient in rapid succession so that more surgeries can be performed by a single surgeon in a single day.

PRIORITY

This application is a divisional of and claims priority under US 35 USC120 from U.S. application Ser. No. 16/392,259, entitled “Corneal GraftAssemblies for Improved Surgical Operations”, and filed Apr. 23, 2019.

The above mentioned applications are hereby incorporated by reference intheir entirety.

DESCRIPTION Technical Field

The present disclosure relates generally to corneal tissue graftassemblies. More specifically, the present disclosure relates to humanor animal tissue sample devices that allow for storage, handling,transportation, visualizing and/or evaluation of the tissue prior to andduring surgical operations. Even more specifically, the presentdisclosure provides for use of the devices with corneal tissue. Thepresent disclosure also relates to surgical method(s) optimization usingsuch devices for administering corneal tissue grafts to subjects in needthereof.

Background

Descemet's Membrane Endothelial Keratoplasty (DMEK) is a cornealtransplantation procedure that enables a one-for-one replacement of adiseased Descemet's membrane and endothelium complex (see Melles G R, etal. Cornea. 2002; 21:415-418; Melles G R, et al. Cornea. 2006;25:987-990; and Price M O, et al. Int Ophthalmol Clin. 2010;50:137-147). DMEK may provide improved post-operative visual outcomes,faster recovery times, and reduced rates of rejection compared to otherendothelial keratoplasty procedures such as Descemet's StrippingAutomated Endothelial Keratoplasty (DSAEK) and Penetrating Keratoplasty(PKP) (see Hamzaoglu E C, et al. Ophthalmology. 2015; Anshu A, et al.Ophthalmology. 2012; 119:536-540; Guerra F P, et al. Ophthalmology.2011; 118:2368-2373; Tourtas T, et al. Am J Ophthalmol. 2012;153:1082-1090 e1082; Guerra F P, et al. Cornea. 2011; 30:1382-1386; andHam L, et al. Arch Ophthalmol. 2009; 127:252-255). While DSAEK and PKremain the most widely performed corneal transplant proceduresworldwide, DMEK is steadily gaining ground on these and other surgicalprocedures in the United States (see Eye Bank Association of America.2018 Eye Banking of America Statistical Report. Washington D.C.: EyeBank Association of America; 2019).

With DMEK gaining popularity among surgeons, eye banks have developedinternal processing programs to assist surgeons in preparing DMEK grafts(see Eye Bank Association of America. 2018 Eye Banking of AmericaStatistical Report. Washington D.C.: Eye Bank Association of America;2019; Holiman J, et al. In: Mohit Parekh.; Stefano Ferrari D P, ed. EyeBanking: Nova Biomedical; 2015:123-139; Deng S X, et al. Am JOphthalmol. 2015; 159:590-596; and Terry M A, et al. Cornea. 2015;34:845-852). Eye bank prepared pre-stripped, pre-peeled, and/orpre-loaded tissues can help reduce both time in the operating room (OR)and potential complications that may arise if tissue preparation failsduring surgery. Pre-stripped, pre-peeled, and/or pre-loaded tissues canalso provide an additional level of quality assurance as eye banks canperform post-processing evaluation of grafts using tissue evaluationinstruments and methods, such as, specular microscopy, slit-lampbiomicroscopy, light microscopy, and/or optical coherence tomography,which are not typically performed in the OR.

US Patent Application No. 2017/0340428 provides a corneal tissue storageand transport kit, where a graft carrier is removably secured to atransport bracket positioned in a 50 mL flask. The glass graft carrier,capped on each end, is removed from the transport bracket using acounter-resistive prying force. The graft carrier has one end taperedfor insertion into the surgical site, while the opening on the opposingend is larger and non-tapered allowing for the graft carrier to sliponto a syringe. The device comprises a container, which can be filledwith a medium, preferably a nutrient medium, and a receiving device,which can be arranged in the container for the graft or implant. Thegraft or implant is arranged in a separate receiving device in thecontainer. As a result, the graft or implant is securely handled bymeans of the receiving device and, at the same time, the graft orimplant secured in the receiving device is protected in the container.

U.S. Pat. No. 10,041,865 provides an assembly for storing and evaluatingcorneal tissue, the assembly having a viewing chamber with a body and alid; and a corneal tissue carrier removably coupled to an inner portionof the body of the viewing chamber. A corneal tissue sample assembly isalso described as having an inner cavity with an opening on each end towhich two removable plugs are provided to close or seal the cornealtissue sample within the cavity.

Therefore, the present disclosure includes the objective of providing adevice and a set that is an assembly of sterile components which allowfor a secure support and/or secure transport, as well as providing asecure and simple graft or implant as the graft or implant is introducedinto a human or an animal body.

Benefits of the present disclosure include significant volume reductionof storage medium, locking connection(s) between the tissue transportassembly and syringe, flexibility of access to the tissue transportassembly, elongated tissue transport device, and a stabilizing device.Such benefits allow for a notable time savings, which can lead to anincrease in the number of surgeries performed by a capable surgeon in agiven day.

Further safety advantages are offered in the present disclosure.Breakage of glass graft carriers may occur when the graft carrier isdirectly engaged by forceps or hemostats and/or pried loose from prongsused to secure the carrier during transport, such as in othercommercially available graft devices/kits provided and described above.Elimination of breakage is successful through forcep engagement of thegraft carrier at the cap of the luer-locking device, preventing the needfor a metal to glass interaction. Breakage is also eliminated as thereis no coupling of the graft carrier to the vial or any form of transportbracket, thereby eliminating the counter-resistive force required toremove the graft carrier from the coupling. Minor compression forcessecure the present disclosure in a safe manner such that the force isrelieved upon opening the vial lid.

Financial benefits include the volume reduction of storage medium by atleast one-third of the used volume for at least one earlier device, aswell as a reduction in surgical time. A vial of storage medium istypically provided in 20 mL volumes at approximately $40-$50 per vial.The storage and transport kit provided herein requires no more than asingle vial of storage medium where other currently available kits mayuse up to 3 vials of storage medium. Additionally, the reduction insurgical time translates to hospital or surgical center cost savings,while performing more reliable procedures per day. Quicker surgery oftentranslates to greater efficiency with respect to patient anesthesiadosing. The use of the present assemblies and associated operatingprocedures also provide for increased revenue for the hospital and/orclinic where the procedures are performed.

Preservation of the graft near a sterile field is achieved through astabilizing base that provides support to prevent spillage whilemaintaining a proper preferred position of the graft carrier. Thetapering and elongation of the graft carrier assembly reduces thelikelihood of aspiration of the graft into a syringe before and/orduring the surgical procedure.

SUMMARY

Assemblies for storing, handling, transporting, viewing, evaluating,and/or shipping corneal tissue are provided. The assembly includes acorneal tissue carrier within a vial, the transport vial removablycoupled to a stabilization base, wherein the ease of access to the graftcarrier allows administering the corneal tissue sample to a patient inrapid succession so that more surgeries can be performed by a singlesurgeon in a single day.

More specifically, the present disclosure describes a kit comprisingcomponents that together complete a fitted assembly for supporting andtransporting a graft or implant wherein the kit comprises; a vial with alid that includes a poly-cone insert, a support base that providessupport so that the vial is able to stand upright and remain motionless,a collarless luer locking cap that includes a female luer lock sectionand a connection portion that includes both a female luer locking endand a barbed male end, wherein the female luer locking end connects withthe luer locking cap and wherein the barbed male end is slideablycoupled to tubing that is further connected to a tissue carrier therebyproviding a completed fitted assembly.

In another embodiment, the female luer locking end connects with asyringe after the collarless luer locking cap has been removed so thatthe completed fitted assembly provides an ability to directly inserttissue into a patient's eye, specifically an anterior chamber and/orcornea by a surgeon, and wherein the tissue is held within the tissuecarrier with a flexible cap with orifices arranged circumferentially andperpendicular to an opening of the tissue carrier that is removablycoupled with a tapered end of the tissue carrier.

In another embodiment, the tissue carrier is a corneal tissue carrierthat carries corneal tissue and wherein the corneal tissue carrier is amodified ophthalmic tube that includes a Jones tube or other modifiedtube-shaped device.

In yet another embodiment, the collarless luer locking cap includes asmall indention that accepts a tip of at least one of a group consistingof forceps, microforceps, hemostat, and suitable sterile device thatallows for ease of grasp of the tissue from the completed fittedassembly and ease of retrieval of the tissue from the vial and whereinthe vial has a base that is either a circular or square-shaped, or thevial is cylindrical and includes at least one flat plane portion.

In another embodiment, the tissue carrier is comprised of eithertransparent or translucent glass, thermoplastics, and/or siliconepolymers, and is designed to hold a lamellar cornea graft, that may be ascrolled corneal tissue graft, from either a primary cell donor orobtained via ex vivo cellular expansion methods that can be seen andinspected by a surgeon prior to and during an operation that utilizesthe corneal tissue.

In another embodiment, the tubing can be flexible and pliable tubing andwherein the tubing comprises materials that are flexible, pliable orrigid materials selected from one or more of a group consisting ofsilicone, silicone rubber, thermoplastics, thermosets, metals, andceramics.

In another embodiment, the syringe is optionally included with the kit.

A complete fitted assembly for supporting and transporting a graft orimplant wherein the assembly comprises; a vial with a lid that includesa poly-cone insert, a support base that provides support so that thevial is able to stand upright and remain motionless, a collarless luerlocking cap that includes a female luer lock section and a connectionportion that includes both a female luer locking end and a barbed maleend, wherein the female luer locking end connects with the luer lockingcap and wherein the barbed male end is slideably coupled to tubing thatis further connected to a tissue carrier thereby providing a completedfitted assembly.

In another embodiment of the assembly, the female luer locking endconnects with a syringe after the collarless luer locking cap has beenremoved so that the completed fitted assembly provides an ability todirectly insert tissue by a surgeon, and wherein the tissue is heldwithin the tissue carrier.

In another embodiment of the assembly, the tissue carrier is a cornealtissue carrier that carries corneal tissue and wherein the cornealtissue carrier may be a modified Jones tube or a modified tube-shapeddevice.

In another embodiment of the assembly, the collarless luer locking capincludes a small indention that accepts a tip of at least one of a groupconsisting of: forceps, microforceps, hemostat, and suitable steriledevice that allows for ease of grasp of the tissue from the completedfitted assembly and ease of retrieval of the tissue from the vial andwherein the vial has a base that is either a circular or square-shaped,or the vial is cylindrical and includes at least one flat plane portion.

In another embodiment of the assembly, the tissue carrier is comprisedof either transparent or translucent glass, thermoplastics, and/orsilicone polymers, and is designed to hold a lamellar cornea graft, thatincludes a possibly scrolled corneal tissue graft, from either a primarycell donor or obtained via ex vivo cellular expansion that can beobserved and inspected by a surgeon prior to and during an operationthat utilizes the corneal tissue.

In another embodiment of the assembly, the tubing can be flexible andpliable tubing and wherein the tubing comprises materials that areflexible, pliable or rigid materials selected from one or more of agroup consisting of silicone, silicone rubber, thermoplastics,thermosets, metals, and ceramics.

A method for performing tissue repair or replacement surgery thatincludes utilizing a fitted assembly within a vial filled with storagemedia fluid and a graft or implant for supporting and transporting thegraft or implant such that when a graft or implant held within theassembly arrives for surgery, a surgeon inspects the graft or implantand the surgeon simply retrieves the fitted assembly that functions as agraft or implant carrier, removes a luer locking cap and attaches asyringe filled with a balanced salt solution (BSS) to a female luerlocking connector wherein the fitted assembly includes flexible tubingand an inlet luer-locking mechanism allowing the surgeon quick andsimple access to the graft or implant and immediate completion ofsurgery to replace or repair the tissue.

In another embodiment of the method, the tissue repair or replacementsurgery is a lamellar keratoplasty surgery utilizing primary cells froma donor, or cells that are obtained via ex vivo methods, which in oftenincludes endothelial keratoplasty, specifically, DMEK surgery.

A method of using a completed fitted assembly for supporting andtransporting a graft or implant that is a tissue wherein the assemblycomprises; a vial with a lid that includes a poly-cone insert, a supportbase that provides support so that the vial is able to stand upright andremain motionless, a collarless luer locking cap that includes a femaleluer lock section and a connection portion that includes both a femaleluer locking end and a barbed male end, wherein the female luer lockingend mates with the luer locking cap and wherein the barbed male end isslideably coupled to tubing that is further connected to a tissuecarrier thereby providing a completed fitted assembly such that when thefemale luer locking end connects with a syringe after the collarlessluer locking cap has been removed so that the completed fitted assemblyprovides an ability to directly insert tissue by a surgeon, and whereinthe tissue is held within the tissue carrier.

In another embodiment of the method, the tissue carrier is a cornealtissue carrier that carries corneal tissue and wherein the cornealtissue carrier is a modified Jones tube or other a modified tube-shapeddevice and the tissue carrier includes a flexible cap with orificesarranged circumferentially and perpendicular to an opening of the tissuecarrier that is removably coupled with a tapered end of the tissuecarrier.

In another embodiment of the method, the collarless luer locking capincludes a small indention that accepts a tip of at least one of a groupconsisting of: forceps, microforceps, hemostat, and suitable steriledevice that allows for ease of grasp of the tissue from the completedfitted assembly and ease of retrieval of the tissue from the vial.

In another embodiment of the method, the tissue carrier is comprised ofeither transparent or translucent glass, thermoplastics, and/or siliconepolymers, and is designed to hold a lamellar cornea graft, that includespossibly a scrolled corneal tissue graft, from either a primary celldonor or obtained via ex vivo cellular expansion that can be observedand inspected by a surgeon prior to and during an operation thatutilizes the corneal tissue.

In another embodiment of the method, the tubing can be flexible andpliable tubing and wherein the tubing comprises materials that areflexible, pliable or rigid materials selected from one or more of agroup consisting of silicone, silicone rubber, thermoplastics,thermosets, metals, and ceramics.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments disclosed herein will become more fully apparent fromthe following description and appended claims, taken in conjunction withthe accompanying drawings. While various aspects of the embodiments arepresented in drawings, the drawings depict only typical embodiments,which will be described with additional specificity and detail throughuse of the accompanying drawings in which:

FIG. 1A is an exploded view of a corneal tissue sample assembly withcorneal tissue carrier and stabilization attachment.

FIG. 1B is an exploded view of a corneal tissue sample assembly withassembled corneal tissue carrier and stabilization attachment.

FIG. 2 is a perspective view of the corneal tissue sample assembly withcorneal tissue carrier for supporting and transporting a graft.

FIG. 3 is a side view of the corneal tissue sample assembly kit of FIGS.1A-2.

FIG. 4 is a view of a poly-cone insert inside the lid intended for thevial seen in FIGS. 1A-3.

DETAILED DESCRIPTION

The various embodiments disclosed herein generally relate to assembliesfor storing, handling, transporting, viewing, evaluating, and/orshipping corneal tissue. The assemblies include a vial, and a cornealtissue (graft) carrier. The assemblies may also include a corneal tissue(graft) sample, wherein the corneal tissue sample is disposed within thecorneal tissue carrier.

Various features of the corneal tissue sample assemblies disclosedherein may be grouped together in a single embodiment, figure, ordescription thereof for the purpose of streamlining the disclosure. Manyof these features may be used alone and/or in combination with oneanother in the various embodiments.

Embodiments may be understood by reference to the drawings, wherein likeparts are designated by like numerals throughout. It will be readilyunderstood that the components of the present disclosure, as generallydescribed and illustrated in the drawings herein, could be arranged anddesigned in a wide variety of different configurations. Thus, thefollowing more detailed description of the embodiments of the assemblyis not intended to limit the scope of the disclosure, but is merelyrepresentative of possible embodiments of the disclosure. In some cases,well-known structures, materials, or operations are not shown ordescribed in detail. While the various aspects of the embodiments arepresented in drawings, the drawings are not necessarily drawn to scaleunless specifically indicated.

The phrases “connected to,” “coupled to,” and “in communication with”refer to any form of interaction between two or more entities, includingbut not limited to mechanical, electrical, magnetic, electromagnetic,fluid, and thermal interaction. Two components may be coupled to eachother even though they are not in direct contact with each other. Forexample, two components may be coupled to each other through anintermediate component. The phrase “fluid communication” is used in itsordinary sense, and is broad enough to refer to arrangements in which afluid (e.g., a gas or a liquid) can flow from one element to anotherelement when the elements are in fluid communication with each other.

FIG. 1A is an exploded view of the assembly [100] for storing, handling,transporting, viewing, evaluating, and/or shipping corneal tissue [105](also referred to herein as a graft).

The assembly [100] for transporting a corneal graft [105] is preparedfor endothelial keratoplasty. There exists a clear vial [110], alsoreferred to as “the vial”, which when assembled will contain 18-22 mL ofcornea storage media [112], and a vial lid [115], preferably with apoly-seal cone insert (FIG. 4) on the interior side of the lid. The vialmay have a base that is a rounded shape, a square shape, or the vial maybe cylindrical with at least one flat plane positioned as a chord alongthe circumference of its surface.

The assembly [100] further includes a corneal tissue carrier, or graftcarrier [120]. In certain embodiments, the corneal tissue carrier [120]may be a Straiko modified Jones tube, a Jones tube, derivatives thereof,or another suitable tissue carrier. In one embodiment, the cornealtissue carrier [120] may be a modified Jones tube for DMEK, and willhave rounded or oval openings measuring 2-5 mm in diameter, one of whichis beveled and measures 1-3.5 mm in diameter, and 36-40 mm in length. Insome embodiments, the corneal tissue carrier [120] may be formed from apolymer, a glass, or another suitable material. In specific embodiments,the corneal tissue carrier [120] may be formed from a biocompatiblematerial (e.g., a biocompatible polymer, a biocompatible glass, etc.).

The corneal tissue [105] is housed inside of an assembly [100]consisting of a transport assembly provided as a corneal tissue carrier[120], with flexible tubing [125] attached to a larger, ringed end [126]of the corneal tissue carrier [120]. A connecting device [130]consisting of both a barbed male end [132], and a female end luerlocking connector [134] with an inlet luer locking mechanism [135], isremovably coupled to the ringed end [126] of the graft carrier [120] viathe flexible tubing [125]. A luer locking cap [140] is designed to screwonto the female luer locking connector [134] of the inlet luer lockingmechanism [135]. A flexible cap [145], with holes arrangedcircumferentially (that may or may not be opposite each other) andperpendicular to the opening of the graft carrier [120], is removablycoupled to the tapered end [150] of the graft carrier [120].

The caps [140, 145] may inhibit or restrict passage of a corneal tissue[105] out of the corneal tissue carrier [120]. In some embodiments, thecaps [140,145] may allow or permit passage of fluid (e.g., apreservation fluid) into and/or out of the corneal tissue carrier [120].In various embodiments, the caps [140, 145] may include one or moreapertures (e.g., openings).

Any combination of caps or plugs (e.g., caps or plugs that allow passageof fluid and/or caps or plugs that inhibit passage of fluid) may be usedwith the corneal tissue carrier [120] disclosed herein.

The graft carrier [120] must be retrieved from the vial [110] in anupright position, making the vial [110] subject to tipping, spillage,and often susceptible to contamination of an otherwise sterile field. Inorder to provide needed additional external stability to preventrequiring assistance from an additional member of the surgical team tostabilize the vial, the vial [110] is supported with a removablenon-sterile base [155]. The base [155] slides onto the vial [110]alleviating the need for additional assistance in removing the graftcarrier [120] from the vial [110], and preventing the surgeon fromhaving to touch the non-sterile external surface of the vial [110], orhaving a circulator hold the vial [110] to prevent tipping over at thetime of retrieval. The base [155] can be injection molded, 3-D printed,or manufactured by any other such means that will produce the base as asingle piece.

FIG. 1B provides an exploded view of the assembly [100] with the cornealtissue carrier [120] in an assembled configuration (which is listed[170] and includes connected components of 140, 130, 125, 120, 105, and145) for insertion into the vial [110]. The vial lid [115] secures thecorneal tissue carrier [120] housing a corneal graft [105], completewith a luer locking cap [140] on one end and a flexible cap [145] on theopposite tapered end [150], within the vial [110]. The tapered end [150]of the corneal tissue carrier [120] is inserted into the vial [110],positioning the luer locking cap [140] at the opening of the vial [110].

The corneal tissue carrier [120] is not coupled to any portion of thevial [110] or vial lid [115], and is free within the vial [110],preferably maintained in place via light compression from the poly-sealcone insert (not shown) on the interior side of the vial lid [115].

The vial [110] is placed within the prongs [160] of the base [155] inorder to maintain an upright position and provide stability.

FIG. 2 is a perspective view of an assembly, kit, or corneal tissuesample assembly [100] for storing, handling, transporting, viewing,evaluating, and/or shipping corneal tissue [105] in a closed, orassembled, configuration.

Transporting the corneal tissue carrier [120] with flexible tubing [125]attached to the non-capped, ringed end [126] is shown in FIG. 2. Theflexible tubing [125] is 0.5-2.5 cm in length. A barbed male luer lockend having a diameter of 1/16- 5/32 inches is inserted into the flexibletubing [125]. The opposite side of the barbed male connector is a femalescrew-on luer locking mechanism.

The graft carrier [120] is not designed to be connected directly to asyringe, and the outer edge of the graft carrier [120] cannot beinserted into the nozzle of a syringe, as the connection is securedthrough the use of an inlet luer-locking mechanism [135] which preventsslippage of the graft carrier [120] from the syringe (not shown) andprovides fluid communication with the graft carrier [120] and fluidcontrol. The connection of the syringe to the graft carrier [120]creates a pre-loaded syringe relieving the surgeon from having to loadthe graft [105] during the surgical procedure.

The syringe does not accompany the assembly [100] as a standard. Neitherof the closure devices are designed for connecting a collar or anadapter.

A collarless luer locking cap [140] is placed on the female luer lockingconnector [134], the luer locking cap [140] possessing a small indentionthat will accept the tip of forceps, microforceps, hemostat, or othersuitable sterile device, and allow for easy grasping of the assembly andretrieval from the vial [110]. When the graft [105] arrives to thesurgeon, the surgeon must simply retrieve the graft carrier [120],remove the luer locking cap [140], and attach their own 3 or 5 mLsyringe filled with balanced salt solution (BSS) to the female luerlocking connector [134]. The step of including the flexible tubing [125]and the inlet luer-locking mechanism [135] saves up to 2 minutes ofvaluable surgeon operating room (OR) time.

FIG. 2 provides the assembly [100], complete with a corneal graft [105]within a corneal tissue carrier [120], in a closed configuration, wherethe corneal tissue carrier [120] and the vial [110] both containsufficient cornea storage medium [112] to substantially immerse thegraft [105] and the graft carrier [120], respectively. The corneastorage medium [112] can be disposed within at least a portion of thecorneal tissue carrier [120] (e.g., when the corneal tissue carrier[120] is disposed within the vial [110]). In certain embodiments, thecornea storage medium [112] may be disposed only within at least aportion of the corneal tissue carrier [120]. In various embodiments, thecornea storage medium [112] may be disposed within the graft carrier[120] such that the corneal tissue [105] is substantially immersed inthe cornea storage medium [112]. The closure is completed with the viallid [115] compressively securing the graft carrier [120] within the vial[110], the flexible tubing [125] providing the corneal tissue carrier[120] acceptability to any angle of retrieval from the vial [110],easing the extraction for the surgeon, thus reducing retrieval time,potential for breakage of the corneal tissue carrier, and tipping of theassembly.

In certain embodiments, the cornea storage medium [112] may beOPTISOL™-GS, OPTISOL™, LIFE4° C.™ (NUMEDIS™, Inc.), EUSOL-C™ (CORNEALCHAMBER™, ALCHIMIA™, Sri), CORNEA COLD® (EUROBIO™), CORNISOL™(AUROLAB™), a derivative thereof, or other suitable preservation fluid.

FIG. 3 illustrates the assembly [110], in a closed configuration,removably coupled to the base providing a kit [300] for storing,handling, transporting, viewing, evaluating, and/or shipping cornealtissue [105]. There are non-sterile components to the kit [300],including the base [155] that provides stability for the vial during thegraft carrier's [120] retrieval from the vial [100]. The loading well[166] (also referred to as a repository or disc), can be included withthe kit as, for example, the corneal tissue [105] may be rinsed,examined, or aspirated into the tissue carrier [120] from this disc[166]. The loading well can be provided as a sterile addition to the kit[100]. The loading well [166] can be injection molded, 3-D printed, ormanufactured by any other such means that will produce the loading wellas a single piece.

It is important to understand and re-emphasize that items [145], [120],[125], [130], [140], [155] and [166] can be/may be put together as a“sterile” kit that other eye banks can use to prepare theassembly/devices described in conjunction with items [110] and [115].The depth and shape of the loading well [166] allows for simpleaspiration of the graft [105] along with an appropriate volume ofstorage media performed by an eye bank technician. The loading well[166] accommodates an ideal volume of storage media as it does notrequire opening an additional vial while ensuring the graft [105] issubstantially submerged in storage media during the loading process.This loading well [166] also facilitates near-horizontal positioning ofthe graft carrier [120] during aspiration to minimize contact betweenendothelial cells and the graft carrier as the graft [105] is aspiratedinto the graft carrier [120] by minimizing any graft contortion as itpasses through the tapered end [150] of the graft carrier [120]. Thiskit allows for a graft to be securely loaded, supported, and/or securelytransported as well as provide a secure and simple graft or implant asthe graft or implant is introduced into a human or an animal body.

The corneal tissue sample could be a pre-stained corneal tissue graft,as no further removal from the corneal tissue carrier for stainingshould be required prior to the attachment of the luer-locking syringe,until administration of the graft to the patient, based on surgeonpreference.

The assembly [100] can further include corneal tissue [105]. The cornealtissue [105] may be suitable for various forms of keratoplasty, lamellarkeratoplasty, and/or endothelial keratoplasty (e.g., DMEK, PDEK, DSAEK,Ultra-thin DSAEK, Bowman's Membrane Transplantation, etc.). In someembodiments, the corneal tissue [105] may be a graft comprising cornealendothelium and Descemet's membrane. In some other embodiments, thecorneal tissue [105] may include corneal endothelium, Descemet'smembrane, and/or pre-Descemet's membrane. In particular embodiments, thecorneal tissue [105] may be a DMEK graft or a graft suitable for a DMEKprocedure. In alternative embodiments, the corneal tissue [105] may alsoinclude stroma. The cellular structures comprising the corneal tissue[105] may be primary cells from a single donor, or cultured via ex vivocellular expansion methodology. As shown, the corneal tissue [105] maybe disposed within the corneal tissue carrier [120].

In some embodiments, at least a portion of each of the vial [110] andthe corneal tissue carrier [120] may be substantially transparent, withthe preferred transparency being clear, such that the corneal tissue[105] can be visible to a user. For example, the corneal tissue [105]may be disposed within the corneal tissue carrier [120], and the cornealtissue carrier [120] including the corneal tissue [105] may be furtherdisposed within the vial [110]. In such configurations, the substantialtransparency of the vial [110] and the corneal tissue carrier [120] mayallow or permit the user to visualize the corneal tissue [105]. Incertain embodiments, the corneal tissue carrier [120] and the vial [110]are substantially transparent and/or substantially clear such that auser may visualize and/or evaluate the corneal tissue [105] disposedwithin the corneal tissue carrier [120] and the vial [110] using cornealtissue evaluation instruments and/or methods such as specularmicroscopy, slit-lamp biomicroscopy, light microscopy, and/or opticalcoherence tomography.

In some embodiments, the corneal tissue carrier [120] is configured tobe coupled to a syringe via a luer-locking mechanism, for example, theringed end [126] of the corneal tissue carrier [120] is coupleable to aluer locking connector designed to accept the tip of a syringe (notshown). In certain embodiments, a portion of medical tubing may becoupled to the corneal tissue carrier [120]. In certain embodiments, themedical tubing may be integral with the corneal tissue carrier [120]. Incertain other embodiments, each of the medical tubing and the cornealtissue carrier [120] may be discrete components.

A cornea storage fluid [112], or preservation fluid, can be disposedwithin at least a portion of the inner portion of the vial [110].Additionally, the preservation fluid [112] can be disposed within atleast a portion of the inner cavity of the corneal tissue carrier [120]such that the corneal tissue [105] is substantially immersed in thecornea storage fluid [112]

As described above, the corneal tissue sample may be a graft comprisingcorneal endothelium and Descemet's membrane. The corneal tissue samplemay be suitable for various forms of lamellar keratoplasty (e.g., DMEK,PDEK, DSAEK, Ultra-thin DSAEK, etc.). In some embodiments, the cornealtissue sample may be a graft comprising corneal endothelium andDescemet's membrane. In some other embodiments, the corneal tissue [105]may include corneal endothelium, Descemet's membrane, and/orpre-Descemet's membrane. In particular embodiments, the corneal tissuesample is a DMEK graft or a graft suitable for a DMEK procedure. Inspecific embodiments, the corneal tissue sample may also include stroma.The cellular structures comprising the corneal tissue [105] may beprimary cells from a single donor, or cultured via ex vivo cellularexpansion methodology.

The method of processing the corneal tissue sample may also includecoupling a cap to an opening of the corneal tissue carrier. As discussedabove, the cap may limit or inhibit passage of the corneal tissue sampleout of the corneal tissue carrier. Furthermore, the cap may allow orpermit passage of the preservation fluid into and out of the cornealtissue carrier.

In some embodiments, a method of administering a corneal tissue samplemay include obtaining a corneal tissue sample assembly. The assembly, asdescribed above, may include a corneal tissue carrier and a cornealtissue sample disposed within the corneal tissue carrier. A method ofadministering a corneal tissue sample may further include administeringor transplanting the corneal tissue sample to a subject. In someembodiments, the subject may be a patient in need of a corneal tissuetransplant.

Any methods disclosed herein comprise one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.

References to approximations are made throughout this specification,such as by use of the term “substantially.” For each such reference, itis to be understood that, in some embodiments, the value, feature, orcharacteristic may be specified without approximation. For example,where qualifiers such as “about” and “substantially” are used, theseterms include within their scope the qualified words in the absence oftheir qualifiers. For example, where the term “substantiallytransparent” is recited with respect to a feature, it is understood thatin further embodiments, the feature can have a precisely transparentconfiguration.

Numerous references have been made to printed publications throughoutthis specification. Each of the above-cited references and printedpublications is individually incorporated herein by reference in itsentirety.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure, orcharacteristic described in connection with that embodiment is includedin at least one embodiment. Thus, the quoted phrases, or variationsthereof, as recited throughout this specification are not necessarilyall referring to the same embodiment.

Similarly, in the above description of embodiments, various features aresometimes grouped together in a single embodiment, figure, ordescription thereof for the purpose of streamlining the disclosure. Thismethod of disclosure, however, is not to be interpreted as reflecting anintention that any claim require more features than those expresslyrecited in that claim. Rather, as the following claims reflect,inventive aspects lie in a combination of fewer than all features of anysingle foregoing disclosed embodiment.

The claims following this written disclosure are hereby expresslyincorporated into the present written disclosure, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.Moreover, additional embodiments capable of derivation from theindependent and dependent claims that follow are also expresslyincorporated into the present written description.

Without further elaboration, it is believed that one skilled in the artcan use the preceding description to utilize the invention to itsfullest extent. The claims and embodiments disclosed herein are to beconstrued as merely illustrative and exemplary, and not a limitation ofthe scope of the present disclosure in any way. It will be apparent tothose having ordinary skill in the art, with the aid of the presentdisclosure, that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of the disclosure herein. In other words, variousmodifications and improvements of the embodiments specifically disclosedin the description above are within the scope of the appended claims.Moreover, the order of the steps or actions of the methods disclosedherein may be changed by those skilled in the art without departing fromthe scope of the present disclosure. In other words, unless a specificorder of steps or actions is required for proper operation of theembodiment, the order or use of specific steps or actions may bemodified. The scope of the invention is therefore defined by thefollowing claims and their equivalents.

We claim:
 1. A method for performing tissue repair or replacementsurgery that includes utilizing a fitted assembly within a vial filledwith storage media fluid and a graft or implant for supporting andtransporting said graft or implant such that when a graft or implantheld within said assembly arrives for surgery, a surgeon inspects saidgraft or implant and said surgeon simply retrieves said fitted assemblythat functions as a graft or implant carrier, removes a luer locking capand attaches a syringe filled with a balanced salt solution (BSS) to afemale luer locking connector wherein said fitted assembly includesflexible tubing and an inlet luer-locking mechanism allowing saidsurgeon quick and simple access to said graft or implant and immediatecompletion of surgery to replace or repair said tissue.
 2. The method ofclaim 1, wherein said tissue repair or replacement surgery is a lamellarkeratoplasty surgery utilizing primary cells from a donor, or cells thatare obtained via ex vivo methods, which in often includes endothelialkeratoplasty, specifically, DMEK surgery.
 3. A method of using acompleted fitted assembly for supporting and transporting a graft orimplant that is a tissue wherein said assembly comprises; a vial with alid that includes a poly-cone insert, a support base that providessupport so that said vial is able to stand upright and remainmotionless, a collarless luer locking cap that includes a female luerlock section and a connection portion that includes both a female luerlocking end and a barbed male end, wherein said female luer locking endmates with said luer locking cap and wherein said barbed male end isslideably coupled to tubing that is further connected to a tissuecarrier thereby providing a completed fitted assembly such that whensaid female luer locking end connects with a syringe after saidcollarless luer locking cap has been removed so that said completedfitted assembly provides an ability to directly insert tissue by asurgeon, and wherein said tissue is held within said tissue carrier. 4.The method of claim 3, wherein said tissue carrier is a corneal tissuecarrier that carries corneal tissue and wherein said corneal tissuecarrier is a modified Jones tube or other a modified tube-shaped deviceand said tissue carrier includes a flexible cap with orifices arrangedcircumferentially and perpendicular to an opening of said tissue carrierthat is removably coupled with a tapered end of said tissue carrier. 5.The method of claim 3, wherein said collarless luer locking cap includesa small indention that accepts a tip of at least one of a groupconsisting of: forceps, microforceps, hemostat, and suitable steriledevice that allows for ease of grasp of said tissue from said completedfitted assembly and ease of retrieval of said tissue from said vial. 6.The method of claim 3, wherein said tissue carrier is comprised ofeither transparent or translucent glass, thermoplastics, and/or siliconepolymers, and is designed to hold a lamellar cornea graft, that includespossibly a scrolled corneal tissue graft, from either a primary celldonor or obtained via ex vivo cellular expansion that can be observedand inspected by a surgeon prior to and during an operation thatutilizes said corneal tissue.
 7. The method of claim 3, wherein saidtubing can be flexible and pliable tubing and wherein said tubingcomprises materials that are flexible, pliable or rigid materialsselected from one or more of a group consisting of silicone, siliconerubber, thermoplastics, thermosets, metals, and ceramics.